Recall Management
Managing recalls and safety alerts related to medical devices is more than another administrative task; it is a critical patient safety function. Setting in place an effective hazards and recall system can reduce a significant source of risk before patient harm occurs.
The Food and Drug Administration Aug. 3 identified Class I recalls of two convenience kit products.
The Food and Drug Administration has identified Class I recalls of two products: certain Astral ventilators by Resmed due to a supercapacitor that may leak over time, and 14Fr Low Profile Introducer Kits by Abiomed due to thrombus formation following prolonged use of the introducer.
Baxter is voluntarily recalling a specific lot of intravenous solution due to a report of particulate matter in the solution identified as cardboard, according to a Food and Drug Administration notice.
The Food and Drug Administration has identified a Class I recall of reprocessed electrophysiology and ultrasound catheters by Medline Industries due to specific lots potentially containing small residual particles.
The Food and Drug Administration has issued an early alert for all heart pump controllers by Abiomed, which sent a correction notice to all customers with updated use instructions.
The Food and Drug Administration has issued a Class I recall correction for certain Boston Scientific ACCOLADE pacemakers and cardiac resynchronization therapy pacemakers after identifying a software-related battery issue that could cause affected devices to enter Safety Mode and limit pacing…
The Food and Drug Administration has identified a nationwide recall.
The Food and Drug Administration has issued an early alert for certain Streamline Airless System Hemodialysis Bloodlines and B3 Low Volume Bloodlines by B. Braun Medical due to preliminary testing that showed a change to the tubing resin led to small air bubbles adhering to the inside of the…
Olympus has expanded a voluntary recall of its ViziShot 2 FLEX Needles due to complaints of device components ejecting or attaching during procedures, the Food and Drug Administration announced Jan. 16. The company said it received reports of one patient death and one patient injury and advised…
The Food and Drug Administration has identified a Class I recall of Baxter Life2000 Ventilation Systems due to a cybersecurity issue discovered through internal testing. The devices are being permanently recalled and the FDA advised customers to stop using the product.